Neuroactive steroids – new possibilities in the treatment of postpartum depression

Česká verzia

Authors: Lucia Žigová; Petra Massarová; Katarína Vranecová; Orsolya Hrubá; Adriana Adamičková; Andrea Gažová
Published in the journal: Čes. slov. Farm., 2022; 71, 140-148
Category: Review Articles
doi: https://doi.org/https://doi.org/10.5817/CSF2022-4-140

Summary

Pregnancy and postpartum period are associated with demanding physical and psychological changes that often lead to the development of psychological disorders. Depression is diagnosed in more than one in six women after childbirth. However, the prevalence of postpartum depression can be much higher because many cases are undiagnosed. In the case of severe depression, the patient is switched to pharmacological treatment, with sertraline being the most commonly used for this diagnosis. A new drug used in the treatment of postpartum depression is brexanolone, which was registered by FDA in 2019. The advantage over conventional therapy is its rapid onset of action. The structure represents the neuroactive steroid – allopregnanolone, which acts as an agonist on the δ-subunit of the GABA receptor and improves the symptoms of postpartum depression. In addition to the registered brexanolone, another steroidal drug, zuranolone, is available in the third phase of the clinical trial. The steroid structure was chemically altered to improve bioavailability and create an oral dosage form. Another synthetic analogue of neuroactive allopregnanolone, known as ganaxolone, did not show a significant reduction in depressive symptoms in the second phase of the clinical trial compared to placebo. Nevertheless, it has great therapeutic potential in the treatment of various types of epilepsy.

Keywords:

postpartum depression – allopregnanolone – brexanolone – zuranolone – ganaxolone

Zdroje

1. Grace S. L., Evindar A., Stewart D. E. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Archives of Women’s Mental Health [online]. 2003; 6(4), 263–274. Dostupné na: doi:10.1007/s00737-003- 0024-6

2. Bloch M., Daly R. C., Rubinow D. R. Endocrine factors in the etiology of postpartum depression. Comprehensive Psychiatry [online] 2003; 44(3) 234–246. Dostupné na: doi:10.1016/S0010-440X(03)00034-8

3. Schiller C. E., Meltzer-Brody S., Rubinow D. R. The Role of Reproductive Hormones in Postpartum Depression. CNS spectrums [online] 2015; 20(1), 48–59. Dostupné na: doi:10.1017/S1092852914000480

4. Pathak R. S. A., Sharma I. Postpartum psychiatric disorders: Early diagnosis and management. Indian Journal of Psychiatry [online] 2015; 57(Suppl 2), S216–S221. Dostupné na: doi:10.4103/0019-5545.161481

5. Doucet S., Dennis C.-L., Letourneau N., Blackmore E. R. Differentiation and Clinical Implications of Postpartum Depression and Postpartum Psychosis. Journal of Obstetric, Gynecologic & Neonatal Nursing [online] 2009; 38(3), 269–279. Dostupné na: doi:10.1111/j.1552- 6909.2009.01019.x

6. Balaram K., Marwaha R. Postpartum Blues [online]. B.m.: StatPearls Publishing [cit. 5.7.2022]. Dostupné na: https://www.ncbi.nlm.nih.gov/books/NBK554546/

7. Davidson M. R. Postpartum Depression. In: Encyclopedia of Family Studies [online]. B.m.: John Wiley & Sons, Ltd.) 2016; 1–4 [cit. 5.7.2022]. Dostupné na: doi:10.1002/9781119085621.wbefs365

8. MKCH 10 (10. Revízia) [online] [cit. 30.4.2022]. Dostupné na: http://www.nczisk.sk/Standardy-v-zdravotnictve/ Pages/MKCH-10-Revizia.aspx

9. Degner D. Differentiating between “baby blues,” severe depression, and psychosis. BMJ (Clinical research ed.) [online] 2017; 359, j4692. Dostupné na: doi:10.1136/ bmj.j4692

10. Štandardy klinická psychológia pre dospelých: SPDTP [online] [cit. 7.7.2022]. Dostupné na: https://www.standardnepostupy. sk/standardy-klinicka-psychologia-pre-dospelych/

11. Mughal S., Azhar Y., Siddiqui W., May K. Postpartum Depression (Nursing). In: StatPearls [online]. Treasure Island (FL): StatPearls Publishing [cit. 9.1.2022] 2021. Dostupné na: http://www.ncbi.nlm.nih.gov/books/ NBK568673/

12. Guille C., Newman R., Fryml L. D., et al. Management of Postpartum Depression. Journal of Midwifery & Women’s Health [online] 2013; 58(6), 643–653. Dostupné na: doi:10.1111/jmwh.12104

13. SPC ZOLOFT 100 mg. ADC.sk [online] [cit. 16.5.2022]. Dostupné na: https://www.adc.sk/databazy/produkty/ spc/zoloft-100-mg-350721.html

14. Kašpárek T. SSRI v graviditě a laktaci. Psychiatrie pro praxi. 2012; 14(1), 37–38.

15. Paroxetine [online] [cit. 10.7.2022a]. Dostupné na: https:// go.drugbank.com/drugs/DB00715

16. SPC SEROXAT 30 mg. ADC.sk [online] [cit. 10.7.2022d]. Dostupné na: https://www.adc.sk/databazy/produkty/ spc/seroxat-30-mg-418765.html

17. Prozac. prozac-article-6-12-referral-annex-i-ii-iii_sk.pdf [online]. [cit. 10.7.2022b]. Dostupné na: https://www. ema.europa.eu/en/documents/referral/prozac-article- 6-12-referral-annex-i-ii-iii_sk.pdf

18. SPC Alventa 75 mg. ADC.sk [online] [cit. 10.7.2022c]. Dostupné na: https://www.adc.sk/databazy/produkty/ spc/alventa-75-mg-673196.html

19. Kimmel M., Clive M., Gispen F. Oxytocin receptor DNA methylation in postpartum depression. Psychoneuroendocrinology [online] 2016; 69, 150–160. Dostupné na: doi:10.1016/j.psyneuen.2016.04.008

20. Mamrut S., Harony H., Sood R., et al. DNA methylation of specific CpG sites in the promoter region regulates the transcription of the mouse oxytocin receptor. PloS One [online] 2013; 8(2), e56869. Dostupné na: doi:10.1371/journal.pone.0056869

21. SPC Oxytocin Ferring-Léčiva 5 IU. ADC.sk [online] [cit. 13.7.2022]. Dostupné na: https://www.adc.sk/databazy/ produkty/spc/oxytocin-ferring-leciva-5-iu-558070. html

22. Mccarthy M. M. The Two Faces of Estradiol: Effects on the Developing Brain. The Neuroscientist: a review journal bringing neurobiology, neurology and psychiatry [online] 2009; 15(6), 599–610. Dostupné na: doi:10.1177/1073858409340924

23. Douma L., Husband C., O’Donnell M. E., et al. Estrogen- related Mood Disorders: Reproductive Life Cycle Factors. Advances in Nursing Science 2005; 28(4), 364– 375.

24. Amodeo G., Laurenzi P. F., Santucci A., et al. Advances in treatment for postpartum major depressive disorder. Expert Opinion on Pharmacotherapy [online] 2020; 21(14), 1685–1698. Dostupné na: doi:10.1080/14 656566.2020.1779702

25. Li H. J., Martinez P. E., Xiaobai L. I., et al. Transdermal estradiol for postpartum depression: results from a pilot randomized, double-blind, placebo-controlled study. Archives of Women’s Mental Health [online] 2020; 23(3), 401–412. Dostupné na: doi:10.1007/s00737-019-00991-3

26. Moses-Kolko E. L., Berga S. L., Kalro B., et al. Transdermal estradiol for postpartum depression: A promising treatment option. Clinical obstetrics and gynecology [online] 2009; 52(3), 516–529. Dostupné na: doi:10.1097/GRF.0b013e3181b5a395

27. Parry B. L. Optimal management of perimenopausal depression. International Journal of Women’s Health 2010; 2, 143–151.

28. da Pozzo E., Costa B., Martini C. Translocator Protein (TSPO) and Neurosteroids: Implications in Psychiatric Disorders. Current Molecular Medicine [online] 2012; 12(4), 426–442. Dostupné na: doi:10.2174/156652412800163451

29. Raux P.-L., Drutel G., Revest J.-M., Vallée M. New perspectives on the role of the neurosteroid pregnenolone as an endogenous regulator of type-1 cannabinoid receptor (CB1R) activity and function. Journal of Neuroendocrinology [online] 2021; e13034. Dostupné na: doi:10.1111/jne.13034

30. Paul S. M., Purdy R. H. Neuroactive steroids. The FASEB Journal [online] 1992; 6(6), 2311–2322. Dostupné na: doi:10.1096/fasebj.6.6.1347506

31. Pinna G. Allopregnanolone, the Neuromodulator Turned Therapeutic Agent: Thank You, Next? Frontiers in Endocrinology [online] 2020; 11, 236. Dostupné na: doi:10.3389/fendo.2020.00236

32. Arslan A. Extrasynaptic δ-subunit containing GABAA receptors. Journal of Integrative Neuroscience [online] 2021; 20(1), 173–184. Dostupné na: doi:10.31083/j. jin.2021.01.284

33. Bortolato M, Coffey B. J., Gabbay V., Scheggi S. Allopregnanolone: The missing link to explain the effects of stress on tic exacerbation? Journal of Neuroendocrinology [online]. 2022; 34(2), e13022. Dostupné na: doi:10.1111/jne.13022

34. Fasipe O. J., Agede O. A., Enikuomehin A. Ch. Announcing the novel class of GABA-A receptor selective positive allosteric modulator antidepressants. Future science OA [online] 2020; 7(2), FSO654. Dostupné na: doi:10.2144/fsoa-2020-0108

35. Meltzer-Brody S., Colquhoun H., Riesenberg R., et al. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebocontrolled, phase 3 trials. Lancet (London, England) [online] 2018; 392(10152), 1058–1070. Dostupné na: doi:10.1016/S0140-6736(18)31551-4

36. Paskova A., Jirak R., Mikesova M., et al. The role of steroids in the development of post-partum mental disorders. Biomedical Papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia [online] 2014; 158(3), 361–364. Dostupné na: doi:10.5507/ bp.2012.098

37. Walkery A., Leader L. D., Cooke E., Vandenberg A. Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders. Drug Design, Development and Therapy [online] 2021; 15, 3017–3026. Dostupné na: doi:10.2147/DDDT.S240856

38. Faden J., Citrome L. Intravenous brexanolone for postpartum depression: what it is, how well does it work, and will it be used? Therapeutic Advances in Psychopharmacology [online]. 2020; 10, 2045125320968658. Dostupné na: doi:10.1177/2045125320968658

39. Leader L. D., O’Connell M., Vandenberg A. Brexanolone for Postpartum Depression: Clinical Evidence and Practical Considerations. Pharmacotherapy [online] 2019; 39(11), 1105–1112. Dostupné na: doi:10.1002/ phar.2331

40. Zimmerman M., Martinez J. H., Young D., et al. Severity classification on the Hamilton depression rating scale. Journal of Affective Disorders [online] 2013; 150(2), 384–388. Dostupné na: doi:10.1016/j.jad.2013.04.028

41. Gerbasi M. E., Meltzer-Brody S., Acaster S., et al. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. Journal of Women’s Health (2002) [online] 2021; 30(3), 385–392. Dostupné na: doi:10.1089/jwh.2020.8483

42. U.S. FOOD AND DRUG ADMINISTRATION. Drugs@FDA: FDA-Approved Drugs [online] [cit. 10.1.2022a]. Dostupné na: https://www.accessdata.fda.gov/scripts/cder/ daf/

43. Kaufman Y., Carlini S. V., Deligiannidis K. M. Advances in pharmacotherapy for postpartum depression: a structured review of standard-of-care antidepressants and novel neuroactive steroid antidepressants. Therapeutic Advances in Psychopharmacology [online]. 2022; 12, 20451253211065860. Dostupné na: doi:10.1177/20451253211065859

44. Dichtel L. E., Nyer M., Dording Ch., et al. Effects of Open-Label, Adjunctive Ganaxolone on Persistent Depression Despite Adequate Antidepressant Treatment in Postmenopausal Women: A Pilot Study. The Journal of Clinical Psychiatry [online] 2020; 81(4), 19m12887. Dostupné na: doi:10.4088/JCP.19m12887

45. MARINUS PHARMACEUTICALS, 2019. Marinus Pharmaceuticals Announces Data from Magnolia and Amaryllis Phase 2 Studies in Women with Postpartum Depression. GlobeNewswire News Room [online] [cit. 29.1.2022]. Dostupné na: https://www.globenewswire. com/news-release/2019/07/23/1886335/32077/en/Marinus-Pharmaceuticals-Announces-Data-from- Magnolia-and-Amaryllis-Phase-2-Studies-in-Women- -with-Postpartum-Depression.html

46. Silberstein S. D., Lipton R. B., Dalessio D. J. Wolff’s Headache and Other Head Pain. B.m.: Oxford University Press 2001.

47. Miziak B., Chrościńska-Krawczyk M., Czuczwar S. J. Neurosteroids and Seizure Activity. Frontiers in Endocrinology [online] 2020; 11 [cit. 21.2.2022]. Dostupné na: https://www.frontiersin.org/article/10.3389/fendo. 2020.541802

48. CENTER FOR DRUG EVALUATION AND RESEARCH, 2022. Novel Drug Approvals for 2022. FDA [online] 2022 [cit. 16.5.2022]. Dostupné na: https://www.fda.gov/drugs/ new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals- 2022

49. MARINUS PHARMACEUTICALS, 2021. A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy Followed by Long-term Open-label Treatment. [online]. Clinical trial registration NCT03865732. B.m.: clinicaltrials.gov [cit. 7.3.2022]. Dostupné na: https://clinicaltrials.gov/ct2/ show/NCT03865732

50. MARINUS PHARMACEUTICALS, 2021. A Phase 2 Open- -label 12-Week Trial of Adjunctive Ganaxolone Treatment (Part A) in Tuberous Sclerosis Complex-related Epilepsy Followed by Long-term Treatment (Part B) [online]. Clinical trial registration NCT04285346. B.m.: clinicaltrials.gov [cit. 7.3.2022]. Dostupné na: https:// clinicaltrials.gov/ct2/show/NCT04285346

51. MARINUS PHARMACEUTICALS, 2021. A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus [online]. Clinical trial registration NCT04391569. B.m.: clinicaltrials.gov [cit. 7.3.2022]. Dostupné na: https://clinicaltrials.gov/ct2/show/ NCT04391569

52. Newport D. J. An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder [online] 2022. Clinical trial registration NCT05254405. B.m.: clinicaltrials.gov [cit. 5.5.2022]. Dostupné na: https:// clinicaltrials.gov/ct2/show/NCT05254405

53. UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL, 2022. Open Label Study of the Efficacy, Safety and Tolerability of Zulresso in the Treatment of Adult Women With Postpartum Psychosis [online]. Clinical trial registration NCT05314153. B.m.: clinicaltrials.gov [cit. 5.5.2022]. Dostupné na: https://clinicaltrials.gov/ct2/show/ NCT05314153

54. Peltier M. Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder [online] 2022. Clinical trial registration NCT05223829. B.m.: clinicaltrials.gov [cit. 5.5.2022]. Dostupné na: https://clinicaltrials.gov/ct2/ show/NCT05223829

55. Hadine J. Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause [online] 2022. Clinical trial registration NCT05329779. B.m.: clinicaltrials. gov [cit. 5.5.2022]. Dostupné na: https://clinicaltrials. gov/ct2/show/NCT05329779

56. SAGE THERAPEUTICS, 2022. Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting [online]. Clinical trial registration NCT05059600. B.m.: clinicaltrials.gov [cit. 5.5.2022]. Dostupné na: https://clinicaltrials.gov/ct2/show/ NCT05059600

57. CENTER FOR DRUG EVALUATION and FDA approves drug for treatment of seizures associated with rare disease in patients two years of age and older. FDA [online]. 2022 [cit. 22.7.2022]. Dostupné na: https://www.fda.gov/drugs/news-events-human- drugs/fda-approves-drug-treatment-seizures-associated- rare-disease-patients-two-years-age-and-older

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